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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Blood Transfer Device
MAVERIC MEDICAL LLC
M6018
In Commercial Distribution

  • 10860002576609 ()
  • 00860002576602 ()
  • 20860002576606 ()


  • Blood collection tube holder, single-use
Stronghold anti-disconnect device for neonate/pediatric tracheostomy tubes
HAMMER-PLANE INC
PDD
In Commercial Distribution

  • 00860002529059 ()
  • 00860002529028 ()
PDD

  • Tracheostomy tube neck holder, single-use
Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch neck flange
HAMMER-PLANE INC
ADD
In Commercial Distribution

  • 00860002529042 ()
  • 00860002529011 ()
ADD

  • Tracheostomy tube neck holder, single-use
Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes
HAMMER-PLANE INC
SSDD
In Commercial Distribution

  • 00860002529004 ()
  • 00860002529035 ()
SSDD

  • Tracheostomy tube neck holder, single-use
No Description
UNITED MEDICAL INC
VY001XS
In Commercial Distribution

  • 00860002339603 ()
  • 00860002339610 ()
  • 00860002339627 ()


  • Vinyl examination/treatment glove, non-powdered
Software that generates standardized metadata descriptions of medical images. The software also de-identifies PHI in metadata and image pixel data of medical images. The output of this functionality is used for various healthcare workflows such as hanging protocols, billing, and research. Using proprietary natural language processing (NLP) and computer vision (CV) algorithms, it reviews information from DICOM images and metadata to identify key attributes of radiological examinations for standardization, and for detecting and redacting PHI. It contains basic functionality such as user access and security, dashboards for analytics, and allows for integration with other devices such as third-party PACS software. Ensight does not aid in any diagnosis or provide any diagnostic information.
Enlitic, Inc.
2.0
In Commercial Distribution

  • 00860002304557 ()


  • Radiology DICOM image processing application software
Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304540 ()


  • Radiology DICOM image processing application software
Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304533 ()


  • Radiology DICOM image processing application software
The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304526 ()


  • Radiology DICOM image processing application software
Discontinued product code.
DERBY DENTAL LABORATORY, INC
POR
Not in Commercial Distribution

  • 00860002302362 ()


  • Orthodontic retainer
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